Estrogen Diastolic Heart Failure

• Status: Terminated
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

Peri-menopausal women will be randomized to hormone replacement therapy or placebo for 12 weeks to determine if markers of systolic and diastolic function change by echocardiography as well as laboratory markers of heart failure, including b-type natriuretic peptide (BNP).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gretchen Wells
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Norethindrone; Norethindrone Acetate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• 28 healthy recently postmenopausal women with last menstrual bleeding 12 months at study entry. Women with last menstrual bleeding within 12 months at study entry are those who are peri-menopausal and for whom the drug is FDA approved.

Exclusion Criteria:

• History of hysterectomy, oophorectomy or both

• History of heart disease including cardiac transplantation, heart failure, bypass surgery or percutaneous intervention, and valve disease defined as moderate or severe valve regurgitation or stenosis

• History of bone disease including non-traumatic vertebral fractures on radiography

• Uncontrolled chronic disease (including uncontrolled diabetes defined as a hemoglobin A1C >8, uncontrolled hypertension defined as a systolic blood pressure >160 mmHg, awaiting organ transplant)

• Previous or current cancer, excluding basal cell carcinoma

• Previous or current thromboembolic disease

• Previous intolerance of Hormone replacement therapy (HRT) or Oral contraception (OC)

• Current or previous use of HRT within the past 3 months

• Current or recent (<12 months) substance abuse, including tobacco use

• No drug interactions with HRT

• No racial or ethnic groups will be excluded